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歐盟（EU）
2023-10-31
【MDCG 2023-4】Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components
2021-03-31
Is your software a Medical Device?
2020-03-31
【MDCG 2020-1】Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software
2019-12-31
【MDCG 2019-16 rev.1】Guidance on cybersecurity for medical devices
2019-10-31
【MDCG 2019-11】Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
2022-07-08
Qualification and Classification of stand alone software
2022-07-08
